The U.S. Food and Drug Administration granted regular approval to alectinib (Alecensa; Genentech) for the treatment of partients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Read full press release. 

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb, Amgen) as a biosimilar to Avastin (bevacizumab, Genentech). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda; Merck) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum- containing chemotherapy and, if appropriate, HER2/neu- targeted therapy. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo; Bristo-Myers Squibb) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib; Bayer) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments know as systemtic therapies. Read full press release. 

The U.S. Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systematic therapy. Read full press release.

The U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatmetn with fluoropyrimidine, oxaliplatin, and irinotecan. Read full press release.

The U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA, Celegene) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydropgenase-2 (IDH2) mutation as detected by an FDA-approved test. Read full press release.

The U.S. Food and Drug Administration granted regular approvals to dabrafenib and trametinib (Tafinlar and Mekinist, Novartis) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. Read full press release.

The U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela, Genentech) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. Read full press release.